- New Ph. Eur. reference standards
- Replacement batches for Ph. Eur. reference standards
- Removal
- Future removal
- Change of sales units
- Information on change of price
- Change of EDQM storage/shipping conditions
See also:
The EDQM announces the availability of:
8 new European Pharmacopoeia (Ph. Eur.) reference standards:
Catalogue code | Name | Unit quantity | Price |
---|---|---|---|
Piperacillin for peak identification CRS |
15 mg |
79 EUR |
|
Ticagrelor CRS |
120 mg |
79 EUR |
|
Ticagrelor impurity E CRS |
15 mg |
79 EUR |
|
Dexpanthenol impurity B CRS |
15 mg |
79 EUR |
|
Sorafenib for peak identification CRS |
15 mg |
100 EUR |
|
Sorafenib impurity H CRS |
10 mg |
100 EUR |
|
Sorafenib tosilate CRS |
120 mg |
100 EUR |
|
Ticagrelor for system suitability CRS |
15 mg |
79 EUR |
Catalogue code | Name | Batch | Unit quantity | Price |
---|---|---|---|---|
Heparin Low-Molecular-Mass for assay BRP |
11 |
1 mL |
90 EUR |
|
Bupivacaine impurity F CRS |
3 |
70 mg |
79 EUR |
|
Carbamazepine CRS |
6 |
180 mg |
79 EUR |
|
Betamethasone dipropionate for system suitability A CRS |
2 |
10 mg |
79 EUR |
|
Laudanosine CRS |
2 |
15 mg |
79 EUR |
|
Progesterone for system suitability CRS |
2 |
5 mg |
79 EUR |
|
Nimesulide for peak identification CRS |
3 |
10 mg |
79 EUR |
|
Zidovudine impurity B CRS |
4 |
5 mg |
79 EUR |
|
Indometacin impurity mixture CRS |
2 |
0.002 mg |
79 EUR |
|
Ursodeoxycholic acid for system suitability CRS |
4 |
1.26 mg |
79 EUR |
|
Sertraline for peak identification CRS |
6 |
5.4 mg |
79 EUR |
|
Sulbactam CRS |
3 |
150 mg |
79 EUR |
|
Rifamycin S CRS |
4 |
100 mg |
79 EUR |
|
Atorvastatin impurity E CRS |
5 |
5 mg |
79 EUR |
|
Acetazolamide for system suitability CRS |
3 |
0.0068 mg |
79 EUR |
|
Articaine impurity A CRS |
4 |
20 mg |
79 EUR |
|
Atracurium for impurity F identification CRS |
2 |
15 mg |
79 EUR |
|
Fluphenazine octanoate CRS |
5 |
20 mg |
79 EUR |
|
Pentobarbital CRS - * psy |
3 |
100 mg |
79 EUR |
|
Levonorgestrel CRS |
3 |
30 mg |
79 EUR |
|
Human immunoglobulin for anticomplementary activity BRP |
2 |
10 g |
79 EUR |
|
Dicycloverine impurity A CRS |
2 |
20 mg |
79 EUR |
|
Polymyxin B sulfate CRS |
7 |
25 mg |
79 EUR |
|
Dexpanthenol CRS |
6 |
20 mg |
79 EUR |
Information on reference standards removed from catalogue
None.
Information on reference standards with a future removal from catalogue
Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.
Catalogue code | Name | Comments |
---|---|---|
Y0000055 |
Acamprosate calcium - reference spectrum |
Removed from Ph. Eur. supplement 10.3 (in application from 1 January 2021) but kept on sales for an additional 6 months according to new policy (see “Change in the policy for withdrawing reference standards from sale”). |
F0253000 |
Fluoxetine hydrochloride |
|
O0120010 |
Ofloxacin impurity A |
|
M0400000 |
Meprobamate CRS |
|
Y0000035 |
Carisoprodol CRS |
|
Y0000036 |
Carisoprodol impurity A CRS |
|
N0050000 |
Nalidixic acid CRS |
|
Y0001792 |
Nalidixic acid impurity C CRS |
|
P2800000 |
Prednisolone acetate |
|
Y0000369 |
Primidone for peak identification |
|
Y0000239 |
Celiprolol for peak identification |
|
Y0000312 |
Celiprolol impurity I |
|
B1000000 |
Betamethasone |
|
Y0000883 |
Adrenaline with impurity F |
|
Y0001128 |
Epinastine for system suitability |
These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 December 2021) to allow users to print the batch validity statement (BVS).
Information on change of sales units
None.
Information on change of price
Please note the price change for Batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability CRS and Everolimus for impurity C identification CRS, to €300 per sales unit.
Information on change of EDQM storage/shipping conditions
None.
Content of the European Pharmacopoeia RS catalogue
The EDQM proposes more than 3 000 Ph. Eur. RS including a wide range of highly-characterised chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP), as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the Ph. Eur. The Ph. Eur. RS catalogue is updated on a daily basis and gives access not only to all the Ph. Eur. RS, but also to:
- Batch Validity Statements (BVSs) for each reference standard;
- Safety Data Sheets and Safety Data Statements for hazardous biologicals;
- leaflets (downloadable PDFs).
For your convenience, the Ph. Eur. RS catalogue is published daily and can be downloaded in in PDF format and in XML format.
If you wish to place an order, you can send your request to the EDQM either:
- via the web store (this form can also be used to confirm a proforma invoice or a quotation you have already received from the EDQM);
- or by e-mail to [email protected] (in this case, please ensure that your order, on your company letterhead, states both the catalogue code and substance name and is attached to your e-mail).